BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK -- IOL

    MDR report key: 1090844 · Received August 1, 2008

    Report

    Report Number
    1119421-2008-00567
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 2, 2008
    Report Date
    July 4, 2008
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQL
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. PRODUCT HISTORY RECORDS COULD NOT BE REVIEWED BECAUSE THE REPORTER DID NOT PROVIDE A LENS SERIAL NUMBER, LOT NUMBER, OR ANY IDENTIFICATION TRACEABLE TO THE MANUFACTURING DOCUMENTATION. ADD'L INFO WAS REQUESTED.

    Description of Event or Problem · 1

    A NURSE REPORTS THAT DURING INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A CHIP IN THE OPTIC WAS NOTED AFTER THE LENS WAS PLACED IN THE EYE. BECAUSE THERE WAS NO OTHER LENS AVAILABLE, THE LENS WAS LEFT IN THE EYE. THE PT DID NOT FEEL WELL AND THE LENS WAS EXPLANTED. THE PT IS REPORTED TO BE DOING "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK -- IOL INTRAOCULAR LENS HQL ALCON MANUFACTURING, LTD. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention